SYNERGY™ XD H7493941808220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729980704), received between May 26, 2021 and Feb 10, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Nonstandard Device; Material Separation

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED. A 2.25 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT; HOWEVER, A STENT DETACHMENT OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309968 ↗
• MalfunctionAug 29, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION. A 2.25 X 8MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON ATTEMPTED REMOVAL, THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM AND WAS NO LONGER POSITIONED ON THE BALLOON. THE DISLODGED STENT WAS SUCCESSFULLY RETRIEVED ALONG WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927028 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY. A 2.25 X 8MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS OPENED OUT OF THE PACKAGE, BUT THE SHAFT WAS VISIBLY BROKEN AT PROXIMAL TO THE HUB. ANOTHER 2.25 X 8MM SYNERGY DES WAS OPENED AND ADVANCED BUT IT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO TWIST THE STENT, IT DID NOT LOOK RIGHT, AND UPON REMOVAL FROM THE SHEATH, THE SHAFT WAS ALSO BROKEN AT PROXIMAL TO THE STENT BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445844 ↗
• MalfunctionDec 22, 2022Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25 X 8MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS PREPARED TO BE DELIVERED. HOWEVER, THE SHAFT GOT KINKED OUTSIDE OF THE HEMOSTASIS VALVE. UPON CONTINUOUS ATTEMPT TO DELIVER THE DEVICE, THE PROXIMAL PORTION OF DELIVERY SHAFT BROKE OFF WHEN TRYING TO DELIVER AROUND THE HARD BEND. THE STENT AND REMAINING SHAFT WERE REMOVED WITH NO OTHER COMPLICATIONS. THE DETACHED PORTION WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038234 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERIAL DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.25 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED THROUGH A GUIDE CATHETER AND GUIDEZILLA GUIDE EXTENSION CATHETER. THE PHYSICIAN DECIDED TO REMOVE THE GUIDEZILLA TO MAKE THE STENT DELIVERY EASIER. HOWEVER, IT WAS NOTED THAT WHEN THE STENT WAS PULLED OUT OF THE BODY, THE SHAFT BROKE IN HALF. THE BROKEN SHAFT WAS PULLED OUT INTACT. A 2.50 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. UPON REMOVAL, IT WAS NOTED THAT THE STENT WAS FRAYED. ANOTHER 2.50 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788449 ↗
• InjuryAug 24, 2022Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT DETACHED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287080 ↗
• MalfunctionMay 26, 2021Positioning Failure; Difficult to Advance; Material Deformation; Positioning Failure; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY. A 2.25 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT RESISTANCE WAS FELT AND COULD NOT INFLATE THE STENT. THE SHAFT WAS BENT DURING INSERTION. HOWEVER, UPON REMOVAL, THE STENT WAS CAUGHT AT THE EDGE WITH GUIDEZILLA GUIDE EXTENSION CATHETER AND WAS DEFORMED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891376 ↗